Baby Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) Intervention Study

NCT01890681 | Completed DMC

• 2 other identifiers: Pro00039195R01DK093838
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. The focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. Outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. Child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.

Conditions

Obesity

Keywords

childhood obesity; child care; infant; toddler

Outcome Measures

Primary Outcomes (2)

• change in weight-for-length z-score

  pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

• change in skinfold thickness

  pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

Secondary Outcomes (3)

• change in child physical activity via accelerometer

  pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

• change in child dietary intake

  pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

• change in child care policies and practices

  pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

Study Arms (2)

Back to Sleep

ACTIVE COMPARATOR

The Back to Sleep arm will encourage safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS) in child care and at home. This include: 1. center and family self-assessment, 2. center intervention materials delivered several times over the 6-month period, and; 3. parent handouts After the intervention period, comparator centers will receive an abbreviated version of the Baby NAP SACC intervention.

Behavioral: Back to Sleep

Baby NAP SACC

EXPERIMENTAL

The intervention will include four complementary and mutually reinforcing components: 1. center and family self-assessment; 2. targeted technical assistance by Baby NAP SACC consultant for providers and parents; 3. training workshops for child care providers; and 4. parent outreach and support.

Behavioral: Baby NAP SACC

Interventions

Baby NAP SACC BEHAVIORAL

Baby NAP SACC

Back to Sleep BEHAVIORAL

Back to Sleep

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• licensed child care centers in North Carolina (NC) serving children birth - 2
• within 120 mile radius of Duke University
• children must be from participating center and 3-18 months of age at baseline
• read/speak English
• adult teachers from infant/toddler classrooms within participating centers
• adult parents of infant/toddlers within participating centers

You may not qualify if:

• child care centers outside of 120 mile radius of Duke University
• children younger than 3 months or over 18 months of age
• parents with children who intend to leave the participating center in \< 12 months

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Duke University Medical Center, Department of Community and Family Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Benjamin Neelon SE, Ostbye T, Hales D, Vaughn A, Ward DS. Preventing childhood obesity in early care and education settings: lessons from two intervention studies. Child Care Health Dev. 2016 May;42(3):351-8. doi: 10.1111/cch.12329. Epub 2016 Mar 14.

  PMID: 26987658 RESULT

• Hewitt L, Benjamin-Neelon SE, Carson V, Stanley RM, Janssen I, Okely AD. Child care centre adherence to infant physical activity and screen time recommendations in Australia, Canada and the United States: An observational study. Infant Behav Dev. 2018 Feb;50:88-97. doi: 10.1016/j.infbeh.2017.11.008. Epub 2017 Dec 7.

  PMID: 29223777 RESULT

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Benjamin Neelon, PhD, RD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Truls Ostbye, MD/PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: August 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)